Health technology assessment and thyroid surgery

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(1)4-09-2013. 7:01. Pagina 198. G Chir Vol. 34 - n. 7/8 - pp. 198-201 July-August 2013. original article. Health technology assessment and thyroid surgery. zio na li. 0490 3 Health technology_Lucchini:-. SUMMARY: Health technology assessment and thyroid surgery. R. LUCCHINI, A. SANGUINETTI, M. MONACELLI, R. TRIOLA, S. AVENIA, C. CONTI, S. SANTOPRETE, N. AVENIA. rameters such as effectiveness, safety, costs of the social and organizational impact. A health technology assessment is a comprehensive, systematic evaluation of the prerequisites for estimating the consequences of using health technology. Main characteristic of HTA is that the problem is tackled using an approach focused on four main elements: - technology; - patient; - organization; - economy. The authors have applied the HTA method for the analysis of the ultrasonic focus dissector on thyroid surgery. They compared the cost of the surgical procedure using the ultrasonic dissector and without it in a case study of 440 patients who underwent thyroidectomy.. izi on. iI nt. The growth of technological innovation, the request for assistance, the rising patient’s expectations and the interest of the industry have led to a rise in the cost of health care systems. In this context the role of the National Health System is not to delay the development or adoption of new technologies, but rather to drive the development selecting priorities and promoting its use. Health Technology Assessment (HTA) is a multidisciplinary and multidimensional approach for analyzing the medical-clinical, social, organizational, economic, ethical and legal implications of a technology (devices, drugs, procedures) through the assessment of multiple pa-. er na. R. LUCCHINI1, A. SANGUINETTI2, M. MONACELLI3, R. TRIOLA1, S. AVENIA1, C. CONTI1, S. SANTOPRETE3, N. AVENIA1. KEY WORDS: HTA - Thyroid surgery.. Introduction. ©. CI. C. Ed. The growth of technological innovation, the increased request for assistance due to the aging population, the rising expectations of patients and the interest of the industry, have led to a rise in the cost of health care systems. In this context the role of the National Health System is not to delay the development or adoption of new technologies, but rather to drive their development, selecting priorities and promoting their use. Health Technology Assessment (HTA) is a multidisciplinary and multidimensional approach for analyzing. University of Perugia, Perugia, Italy Endocrine Surgical Unit 2 A.O. “Santa Maria” of Terni, Terni, Italy Department of Senology 3 University of Perugia, Perugia, Italy Thoracic Surgery Unit 1. © Copyright 2013, CIC Edizioni Internazionali, Roma. 198. the medical-clinical, social, organizational, economic, ethical and legal implications of a technology (devices, drugs, procedures), through the assessment of multiple dimensions such as effectiveness, safety, costs the social and organizational impact (1-3). The objective is to assess the actual and/or potential of the technology, both prior to and during the entire life cycle, as well as the consequences of the introduction or exclusion of an intervention for the health system in the economy society. This methodology has been applied to evaluate the opportunity to introduce routine use in thyroid surgery of the ultrasonic dissector Harmonic focus.. Patients and methods On 2012, in the Unit of endocrine surgery of the Department A.O. “S. Maria” (Terni, Italy), 220 thyroidectomies were carried out using the focus and 220 without instruments. Stored data has been matched with complications, hospitalization time and post-operative consequences on the patient in the use of this technology. The data was analyzed using the check list of mini-HTA..

(2) 0490 3 Health technology_Lucchini:-. 4-09-2013. 7:01. Pagina 199. Health technology assessment and thyroid surgery. iI nt. Discussion. zio na li. The data analysis emphasizes that the use of Harmonic Scalpel (HS) in thyroid surgery involves a reduction of operative time (Table 2). In order to estimate the total cost for each procedure we have considered: the technology purchasing cost, involved staff cost, the cost of the operating room, the cost of hospitalization. The estimated total cost for the procedure, obtained by adding all the cost items previously calculated (see Tables 3 to 4), was subsequently linked to the value DRG 290 applied by the Umbria region for the payment of work performed on an inpatient ordinary (Table 5). The hospital cost estimated by our analysis of procedures performed with standard tool is € 3,055, while the estimated cost of patients operated with Harmonic is € 2,768.. the usefulness of each procedure. The HTA started in the U.S. during end of 60s years, it is an analytical tool to assess the economic, social and legal support of new technologies. Therefore it represents the ‘bridge’ between the scientific and management world. The purpose of HTA is to assist and to advise the health management to drive the health policy. It has been applied for the first time to assess the possibility of incorporating new technologies in radiology services (1-3). HTA is divided into macro, meso e mini. The macro-HTA used to support health policy and macroeconomic. The meso-HTA, also known in the literature as Hospital Based HTA, is designed to support the governance, to divulge qualitative and quantitative standards of care and to encourage the timely transfer of macro-HTA in the health care. The mini-HTA regards, however, the decision-making process directly in the conduct of clinical departments. Meso- and mini-HTA experience of the Italian health companies have been implemented in the following areas: performance (day surgery, specialist outpatient, home care, etc.), clinical-organization (guidelines, care pathways, audit, etc.), investment plan and management of medical equipment and medical devices, directly in the decision-making process. The Italian HTA report is based on the Danish mo-. er na. Results. The increase of the technology, the increase of the average life, the need to reduce the cost of health benefits has led to the development of methods for estimating. izi on. TABLE 1 - CHECK-LIST OF THE MINI-DACEHTA HTA REPORTS. 1) Who is the proponent (hospital, department, person)? 2) What is the name/define medical technology? 3) What are the parties involved in the proposal?. ©. CI. C. Ed. Technology 4) To be used as an indication of therapeutic technology? 5) How can you compare/compare the new technology and the traditionally used? 6) There are already scientific publications about it (by a department or by others)? 7) List the important references and give an assessment of the strength of the evidence. 8) What effect causes the patient to the proposal in terms of diagnosis, treatment, care, rehabilitation and prevention? 9) The proposal involves risks, adverse effects or contraindications to other reasons? 10) There are already studies on the effects of the proposal to other hospitals in Italy or abroad? 11) The proposal was recommended by the Ministry of Health, an association of doctors, etc.? If yes, specify by whom. 12) In the past, it has already been made by the department a request for such a proposal? Patient 13) The proposal involves ethical or psychological considerations? 14) It is expected that the proposal affects the quality of life of the patient? Organization 15) What are the effects of the proposal on staff, in terms of information, training and working environment? 16) The proposal may be implemented in the hospital? 17) The proposal will have on other departments or hospital services? 18) How does the proposal affect the collaboration with other hospitals, regions, primary care (in the event that changes occur in the treatment plan required)? 19) When the proposal can be made? 20) The proposal is already made in Italy or abroad? 21) There are initial costs of labor, rehabilitation, training, etc.? 22) What are the consequences, in terms of activities scheduled for the next two years? 23) What is the annual cost, or additional savings for the hospital over the next two years? 24) What is the total, or additional savings over the next two years? 25) As an additional cost or savings expected for other hospitals, industries, etc.? 26) What is the margin of error that invests these calculations?. 199.

(3) 0490 3 Health technology_Lucchini:-. 4-09-2013. 7:01. Pagina 200. R. Lucchini et al. TABLE 2 - INVOLVED STAFF COST.. Surgeon Surgeon II level Anaesthetist Nurse. 1 2 1 1. Spent time for procedure using Harmonic (min). Spent time for Gross cost procedure without per year Harmonic (min) (€) (min). 67,71 67,71 113,7 113,7. 96,67 96,67 143,33 143,33. 77.633,40 77.633,40 77.633,40 39.602,57. Working time per year. Unit reta €/min (€). Cost with Harmonic procedure (€). Cost without Harmonic procedure. 118560 118560 118560 112320. 0,65 0,65 0,65 0,35. 44 89 74 40. 63,30 126,60 93,85 50,54. 248. 334. zio na li. Personal involved in each procedure. er na. Total Amount. TABLE 3.1 - AVERAGE COST OF OPERATING ROOM AND HOSPITALIZATION ABOUT HARMONIC FOCUS PROCEDURE. Hospitalization cost. Operating room cost. Unit rate. Day. Total. Hourly cost. Operating cost rate €/min. Procedure time (min). Total. Typical. € 500. 2.04. € 1.020. € 441,81. € 8,27. 113,7. € 940,30. iI nt. Admission. TABLE 3.2 - AVERAGE COST OF OPERATING ROOM AND HOSPITALIZATION ABOUT STANDARD PROCEDURE. Hospitalization cost Unit rate. Typical. € 500. Day. Total. izi on. Admission. Operating room cost. 3. € 1.500. Devices cost. Ed. TABLE 4.1 - ESTIMATED COST WITH HARMONIC FOCUS PROCEDURE. Staff cost. C. € 560,45 € 247,55. € 940,30. 1.020. Total € 2.768. del which identifies the following four points (5-8): 1 - Technology - To examine the technology considered to clarify the application and the target, taking into account the possible alternatives, investigate any national or international guidelines; 2 - Patient - To examine all aspects that impact on the patient from the use of technology, analysis of reference, the efficacy, safety, risk / benefit, social and ethical aspects; 3 - Economic evaluation - To assess the economic consequences of the use of technology; 4 - Organization - It is analyzed the influence of technology on the organization of the structure.. CI ©. Operating Hospitalization room cost cost. 200. Hourly cost. Operating cost rate €/min. Procedure time (min). Total. € 441,81. € 8,27. 143,33. € 1.185,34. TABLE 4.2 - ESTIMATED COST WITH STANDARD PROCEDURE. Devices cost. Staff cost. Operating Hospitalization room cost cost. € 36,15 € 334,29 € 1.185,34. € 1.500. Total € 3.055,8. TABLE 5 - ESTIMATED COST PER PROCEDURE COMPARED TO TUC DRG 290 RATE (E.G YEAR 2009). DRG 290 “Thyroidectomy” (Umbria) € 4.974. The mini-HTA (see Table 1) consists of a checklist that must be completed by who proposes the purchase of a technology for a specific group of patients with a specific clinical and here may be used as a basis for decisionmaking. The checklist includes: description of the technology, safety and efficacy, therapeutic use, economic and organizational aspects..

(4) 0490 3 Health technology_Lucchini:-. 4-09-2013. 7:01. Pagina 201. Health technology assessment and thyroid surgery. According to economic point of view, the cost of the single intervention with focus is less than the traditional one (tables 2 to 5). This study should allow to enter the device in the routine surgery. The methodology is extremely useful for assessing the appropriateness of a new technology by analyzing the quality of the instrument and cost benefits for the patient and for the economy.. zio na li. The application of the methodology to the use the scissors ultrasonic focus has allowed the benefits identification for the patient (better control of haemostasis, reducing the time of hospitalization) and for the organization of the hospital (see Tables 2 to 5) (3, 4). In fact, the reduction of operating time and hospitalization has allowed us to optimize the use of the operating room and beds in the ward (10-15).. References. er na. 10. He Q, Zhuang D, Zheng L, Zhou P, Chai J, Lv Z. Harmonic focus in total thyroidectomy plus level III-IV and VI dissection: a prospective randomized study. World J Surg Oncol 2011;9:141. 11. Mourad M, Rulli F, Robert A, Scholtes JL, De Meyer M, De Pauw L. Randomized clinical trial on Harmonic Focus shears versus clamp-and-tie technique for total thyroidectomy. Am J Surg 2011;202:168-74. 12. Markogiannakis H, Kekis PB, Memos N, Alevizos L, Tsamis D, Michalopoulos NV, Lagoudianakis EE, Toutouzas KG, Manouras A. Thyroid surgery with the new harmonic scalpel: a prospective randomized study. Surgery 2011;149:411-5. 13. Miccoli P, Materazzi G, Miccoli M, Frustaci G, Fosso A, Berti P. Evaluation of a new ultrasonic device in thyroid surgery: comparative randomized study. Am J Surg 2010;199:736-40. 14. Hallgrimsson P, Lovén L, Westerdahl J, Bergenfelz A. Use of the harmonic scalpel versus conventional haemostatic techniques in patients with Grave disease undergoing total thyroidectomy: a prospective randomised controlled trial. Langenbecks Arch Surg. 2008;393:675-80. 15. D'Ajello F, Cirocchi R, Docimo G, Catania A, Ardito G, Rosato L, Avenia. Thyroidectomy with ultrasonic dissector: a multicentric experience. G Chir 2010;31:289-92.. ©. CI. C. Ed. izi on. iI nt. 1. Favaretti C, Torrib E. Che cos’è l’Health Technology assessment, RIMeL /IJLaM 2007;3(Suppl.). 2. Battista RN. Expanding the scientific basis of health technology assessment: a research agenda for the next decade. Int J Technol Assess Health Care 2006;22:275-80. 3. Banta D. The development of health technology assessment. Health Policy 2003;63:121-32. 4. Francesconi A. Innovazione organizzativa e tecnologica in sanità. Il ruolo dell’health technology assessment. Franco Angeli, Milano, 2007. 5. Battista RN, Hodge MJ. The evolving paradigm of health technology assessment: reflections for the millennium. CMAJ 1999;160:1464-7. 6. Favaretti C. È l’ora anche in Italia della valutazione della tecnologia sanitaria? Clinical Governance 2007;3:1-3. 7. Carta di Trento. http://www.apss.tn.it. 8. Cicchetti A. L’HTA nel management delle organizzazioni sanitarie: principi, metodi e applicazioni nel contesto del SSN. Clinical Governance 2007;3:31-8. 9. Agenzia Nazionale per i Servizi Sanitari Regionali. Health Technology Assessment. I Quaderni di Monitor: elementi di analisi e osservazione del sistema salute. 2009; IV suppl. n. 23.. 201.

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